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Evaluating efzofitimod for lung disease related to systemic sclerosis

Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

Phase 2 Interventional aTyr Pharma, Inc. · NCT05892614

This study is testing a new medication called efzofitimod to see if it can help people with lung disease caused by systemic sclerosis feel better and improve their lung function.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment25 (estimated)
Ages18 Years and up
SexAll
SponsoraTyr Pharma, Inc. Industry-sponsored
Drugs / interventionsrituximab, tocilizumab, imatinib, nilotinib, dasatinib, methotrexate, cyclophosphamide, prednisone
Locations15 sites (Los Angeles, California and 14 other locations)
Trial IDNCT05892614 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the efficacy, safety, and tolerability of efzofitimod in patients suffering from interstitial lung disease associated with systemic sclerosis. It consists of two parts: a double-blind, randomized, placebo-controlled phase where participants will receive either efzofitimod or a placebo for 20 weeks, followed by an optional open-label extension for those who complete Part A. The study aims to measure improvements in lung function and skin condition in participants diagnosed with systemic sclerosis-related interstitial lung disease.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with systemic sclerosis and interstitial lung disease, who have been on mycophenolate or an equivalent immunosuppressant.

Not a fit: Patients with severe pulmonary disease or those who do not meet the inclusion criteria for systemic sclerosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with systemic sclerosis-related interstitial lung disease.

How similar studies have performed: While similar studies have explored treatments for interstitial lung disease, the specific approach with efzofitimod in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Diagnosis of SSc based on ACR/ EULAR criteria (2013)
2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1
3. HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement \> 10%
4. Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
5. MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with maximum tolerated dose of MMF is acceptable, if \< 2 gm/day, provided the cumulative duration of dosing has exceeded 3 months, OR An adequate dose and duration of an alternate immunosuppressant with a stable dose for the 4 weeks prior to baseline is also allowed.

Exclusion Criteria:

1. Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7
2. Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
3. HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
4. Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
5. Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate \[MTX\], azathioprine \[AZA\], or leflunomide)
6. Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab, cyclophosphamide, pirfenidone, tyrosine-kinase inhibitors (e.g., imatinib, nilotinib, dasatinib)
7. Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products
8. History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening

Where this trial is running

Los Angeles, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Interstitial Lung DiseaseILDSSc-ILDlung inflammationfibrosispulmonary functionefzofitimodsystemic sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.